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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
Classification Nameiliac covered stent, arterial
Generic Nameiliac covered stent, arterial
Applicant
W. L. Gore & Associates, Inc.
3250 west kiltie lane
flagstaff, AZ 86005
PMA NumberP160021
Date Received07/05/2016
Decision Date01/27/2017
Product Code
PRL[ Registered Establishments with PRL ]
Docket Number 16M-0560
Notice Date 02/27/2017
Advisory Committee Cardiovascular
Clinical Trials NCT02080871
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5mm - 13mm and lesion lengths up to 110mm, including lesions at the aortic bifurcation.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S004 
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